Convalescent Plasma EUA ‘Could Have Been Done Better’ But Not A ‘Total Catastrophe’ – FDA’s Marks
Expanded access program for COVID plasma grew bigger than FDA anticipated, and the agency should have pushed harder for randomized clinical trials earlier, CBER director says. Although unapologetic about the EUA, Marks regrets there was not a better understanding of product quality attributes at the time of authorization.
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Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.
US may be making common crisis-era mistake with Tpoxx trial design that prioritizes access over knowledge, ultimately restraining development of data needed to make the best treatment decisions with the potential Monkeypox treatment, particularly for the most vulnerable patients.
Pfizer/BioNtech’s and Moderna’s updated bivalent Omicron booster doses will be available in coming days. Pfizer/BioNtech has an ongoing study in individuals 12 and older and are preparing EUA application for those 6 months and older. Moderna completed enrollment of 512 participants in a Phase 2/3 trial.